Hypertension ArterialORCHIDNCT05942729
Etiological DiagnOsis of caRdiac Diseases Based on echoCardiograpHIc Images and Clinical Data.
An observational study of Hypertension Arterial and Hypokinetic, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Research hypothesis - Recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. In this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Arterial, Hypokinetic, Cardiomyopathies
- What is being tested?
- Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two distinct populations are targeted in this project. The first concerns patients with hypokinetic cardiomyopathy for whom echocardiographic data do not easily distinguish between a cause related to coronary artery disease or related to primary myocardial dysfunction, imposing the performance of an invasive intervention, i.e., a coronary angiography. The second concerns patients with left ventricular hypertrophy, whose etiology can be diverse and whose assessment is particularly exhaustive and costly. In this project, we will study the two most frequent causes: arterial hypertension and infiltrative myocardial disease. The cohort will be composed in a balanced way with respect to the four pathologies mentioned above as well as through data from patients without significant heart disease. This database will be constructed from patients who have been hospitalized at the Cardiology Department during the period January 2018 to December 2022.
Who may be able to join
- Patients with transthoracic echocardiography with satisfactory image quality (sufficient echogenicity)
Who cannot join
- Minor patients
- Patients under curatorship or guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Lyon Sud
Pierre-Bénite, 69310
Pierre-Yves COURAND, MD, PhD, 04.78.86.57.37 ext. +33, pierre-yves.courand@chu-lyon.fr
Pierre-Yves COURAND, MD, PhD
About this study
Research hypothesis - Recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. In this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that, combined with relevant patient data, will allow the development of robust and accurate digital tools for etiological diagnosis.
Objectives - Based on key advances recently obtained in image analysis, notably by members of the consortium, the objective of this project is to develop rigorous and explainable cardiac disease prediction models from echocardiography based on the transformer paradigm (AI). The strength of this study lies in the development of a strong AI framework to model the complex interactions between high-quality image-based measurements extracted from echocardiograms and relevant patient data to automatically predict etiological diagnosis of cardiac diseases
- Being tested
- Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone
- Keywords
- Hypertension, HTN, Arterial Hypertension, Artificial Intelligence, AI, Cardiac remodelling, Left ventricular hypertrophy
- Medical subject headings
- Hypertension, Sedentary Behavior, Cardiomyopathies, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data aloneOther
The origin of the pathology will have been previously diagnosed for each patient thanks to complementary examinations performed as part of routine care (e.g. cardiac CT, cardiac MRI, coronary angiography, thorough biology, nuclear medicine). This information will be used (i) to guide the learning of the AI method developed during the project from a sub-population (80% of the collected database will be used to train the algorithms); (ii) to serve as an evaluation criterion from a test sub-population (remaining 20% of the collected database)
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypokinetic cardiomyopathy. | The first arm includes patients with hypokinetic cardiomyopathy for whom echocardiographic data do not readily distinguish between a cause related to coronary artery disease or related to primary myocardial dysfunction, requiring invasive intervention, i.e., coronary angiography. Receives: Other: Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone | |
| Patients with left ventricular hypertrophy related to hypertension/infiltrative myocardial disease | The second arm includes patients with left ventricular hypertrophy, whose aetiology may be various and whose workup is particularly extensive and expensive. Receives: Other: Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the comparison of the performance of the etiological diagnosis obtained by the artificial intelligence with the etiological diagnosis already established and validated by a physician from the complementary examinations performed on the targeted patients.
The origin of the pathology being previously diagnosed for each patient thanks to complementary examinations carried out in routine (e.g.: cardiac scanner, cardiac MRI, coronary angiography, thorough biology, nuclear medicine). This information will be used (i) to guide the learning of the AI method developed during the project from a sub-population (80% of the collected database will be used to train the algorithms); (ii) to serve as an evaluation criterion from a test sub-population (remaining 20% of the collected database). In addition, visualization tools will be developed to allow clinicians to analyze and interpret the results, particularly with respect to the decision mechanism performed by the algorithm to predict the origin of the pathology. In particular, attention maps will be displayed that will simply allow clinicians to see which data or part of the data was assembled in order to make the decision.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ArterialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942729
- Sponsor's protocol ID
- 69HCL22_0819
- Acronym
- ORCHID
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiological DiagnOsis of caRdiac Diseases Based on echoCardiograpHIc Images and Clinical Data.
- ClinicalTrials.gov ID
- NCT05942729
- Acronym / sponsor ID
- ORCHID / 69HCL22_0819
- Keywords
- Hypertension, HTN, Arterial Hypertension, Artificial Intelligence, AI, Cardiac remodelling, Left ventricular hypertrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research hypothesis - Recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. In this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that, combined with relevant patient data, will allow the development of robust and accurate digital tools for etiological diagnosis.
Objectives - Based on key advances recently obtained in image analysis, notably by members of the consortium, the objective of this project is to develop rigorous and explainable cardiac disease prediction models from echocardiography based on the transformer paradigm (AI). The strength of this study lies in the development of a strong AI framework to model the complex interactions between high-quality image-based measurements extracted from echocardiograms and relevant patient data to automatically predict etiological diagnosis of cardiac diseases
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hypokinetic cardiomyopathy. | – | Other: Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data aloneThe first arm includes patients with hypokinetic cardiomyopathy for whom echocardiographic data do not readily distinguish between a cause related to coronary artery disease or related to primary myocardial dysfunction, requiring invasive intervention, i.e., coronary angiography. |
| Patients with left ventricular hypertrophy related to hypertension/infiltrative myocardial disease | – | Other: Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data aloneThe second arm includes patients with left ventricular hypertrophy, whose aetiology may be various and whose workup is particularly extensive and expensive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two distinct populations are targeted in this project. The first concerns patients with hypokinetic cardiomyopathy for whom echocardiographic data do not easily distinguish between a cause related to coronary artery disease or related to primary myocardial dysfunction, imposing the performance of an invasive intervention, i.e., a coronary angiography. The second concerns patients with left ventricular hypertrophy, whose etiology can be diverse and whose assessment is particularly exhaustive and costly. In this project, we will study the two most frequent causes: arterial hypertension and infiltrative myocardial disease. The cohort will be composed in a balanced way with respect to the four pathologies mentioned above as well as through data from patients without significant heart disease. This database will be constructed from patients who have been hospitalized at the Cardiology Department during the period January 2018 to December 2022.
Key inclusion criteria (1 listed)
- Patients with transthoracic echocardiography with satisfactory image quality (sufficient echogenicity)
Key exclusion criteria (2 listed)
- Minor patients
- Patients under curatorship or guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data aloneThe origin of the pathology will have been previously diagnosed for each patient thanks to complementary examinations performed as part of routine care (e.g. cardiac CT, cardiac MRI, coronary angiography, thorough biology, nuclear medicine). This information will be used (i) to guide the learning of the AI method developed during the project from a sub-population (80% of the collected database will be used to train the algorithms); (ii) to serve as an evaluation criterion from a test sub-population (remaining 20% of the collected database) | Other | Patients with hypokinetic cardiomyopathy., Patients with left ventricular hypertrophy related to hypertension/infiltrative myocardial disease |
Primary outcome
the comparison of the performance of the etiological diagnosis obtained by the artificial intelligence with the etiological diagnosis already established and validated by a physician from the complementary examinations performed on the targeted patients.
Time frame: Baseline
The origin of the pathology being previously diagnosed for each patient thanks to complementary examinations carried out in routine (e.g.: cardiac scanner, cardiac MRI, coronary angiography, thorough biology, nuclear medicine). This information will be used (i) to guide the learning of the AI method developed during the project from a sub-population (80% of the collected database will be used to train the algorithms); (ii) to serve as an evaluation criterion from a test sub-population (remaining 20% of the collected database). In addition, visualization tools will be developed to allow clinicians to analyze and interpret the results, particularly with respect to the decision mechanism performed by the algorithm to predict the origin of the pathology. In particular, attention maps will be displayed that will simply allow clinicians to see which data or part of the data was assembled in order to make the decision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Arterial and Hypokinetic, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the comparison of the performance of the etiological diagnosis obtained by the artificial intelligence with the etiological diagnosis already established and validated by a physician from the complementary examinations performed on the targeted patients. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.